To obtain a licence and permit to import a medicine containing a controlled substance approved, or notified, under the Special Access Scheme, the medical practitioner must complete the following:

Note: Each consignment of goods requires a separate permit to import.

All applications for a licence/permit to import an unapproved medicine containing a controlled substance under the SAS must include either:

  • a completed notification form (SAS Category A); or
  • the decision letter from the TGA confirming that a particular course of drug treatment has been approved (SAS Category B).

An Authorised Prescriber wishing to import unregistered medicines directly or importers importing for clinical trials should refer to the page on Import of controlled substances and complete, as appropriate:

Importer's responsibilities

As the importer, it is your responsibility to:

  • ensure that the triplicate copy of the permit is endorsed by:
    • Australian Border Force, and
    • the importer or agent for the importer
  • return the endorsed triplicate copy to the Office of Drug Control no later than 14 days after the importation has occurred.

Failure to comply with this, or any other condition, could result in the cancellation of import licences.